ES2547355T3 - Implant to regulate a flow - Google Patents

Abstract

An implant (10, 100, 120) for regulating the flow of fluid comprising: a tube (12) comprising an inlet end, an outlet end and a conduit (14, 102, 122) of the tube extending between the inlet end and the outlet end to allow fluid to flow through the conduit (14, 102, 122) of the tube; a flange (18) located at the outlet end of the tube (12) and a retention projection (20) near the inlet end, the flange (18) having grooves (19) on each side of the flange (18); and a means to temporarily block, totally or partially, the flow of fluid through the tube conduit.

Description

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DESCRIPTION

Implant to regulate a flow

Field of the Invention

The invention generally relates to medical implants used to regulate the flow of fluids within the body. The invention can be applied, for example, to ophthalmic implants for glaucoma treatment.

Background of the invention

Medical implants are known and used to regulate the flow of fluids within the human body. An application for the use of such implants is applied in the treatment of glaucoma. Typical ophthalmic implants use drainage tubes for the release of aqueous humor from the eye to relieve intraocular pressure (IOP).

Various disadvantages have sometimes been associated with previous implants. For example, implants that use valve mechanisms to regulate fluid flow have a dangerous malfunction due to defects in and / or failure of such valve mechanisms. Depending on such factors as the implantation site, some implants tend to clog while being used due to the tissue that covers the inlet end or the drain outlet end. In addition, insertion operations have sometimes been required before implants that are complicated, expensive and time-consuming, for example, that need to be sutured once the implant is in place.

US 5,300,020 shows a device that can be surgically implanted to drain aqueous fluid from the anterior chamber of the eye in a controlled manner, where the device includes a way to control the velocity of the aqueous flow.

Patents and applications incorporated by reference

Some patents describe and illustrate implants aimed at overcoming some of the disadvantages associated with the previous implants, as well as the discharge devices for such implants, use procedures for such implants and manufacturing procedures for such implants.

For example, implants, discharge devices, use procedures, and manufacturing procedures are described and illustrated in US Pat. 5,868,697 and US Patent No. 5,702,414, both of which are the property of the assignee of this application.

Summary of the invention

An object of the invention is to provide an implant to regulate the flow that allows the implant to be inserted in an efficient and relatively simple procedure. The invention is defined in independent claims 1. Additional preferred embodiments of the invention are defined in the dependent claims.

In one embodiment according to the invention, the implant having a tube to allow fluid flow has an outer flange at the outlet end and one or more retention projections near the inlet end. An introducer or discharge device for implanting the implant has a central perforation to accommodate the implant during the implantation procedure. The implant and discharge device are designed so that when the implant is loaded into the discharge device, the projection or retention projections of the implant protrude from the discharge device to act as a hook or hooks during the procedure.

According to a procedure for using the implant and discharge device, the implant is loaded into the discharge device with the retention projection exiting the discharge device. The discharge device and the implant then penetrate the tissue through which drainage is desired, for example, the sclera of an eye. Once the retention projection has completely penetrated through the tissue, the discharge device is removed. The retention projection acts as a hook that engages the inner surface of the tissue, causing the implant to remain implanted in the tissue when the discharge device is removed.

The retention projection can be made, for example, of an elastic material, so that it is capable of flexing inwardly against the implant tube during penetration through the tissue. Alternatively, the retention projection can be designed to initially rest relatively flatly against the tube for easier penetration and to prevent tearing of the tissue, with a mechanism to extend the retention projection outward in implant implantation.

The implant can be molded of a suitable material, for example silicone. To provide the passage of the implant, a thin wire can be used during the molding process. The implant can alternatively be constructed of stainless steel or any other suitable material.

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The implant can have several mechanisms to change the configuration of the flow path. For example, a rod to control the flow or other obstruction can be placed in the tube conduit to change the dimensions within the tube conduit. This rod or obstruction may be temporary. For example, it can be made of absorbable (biodegradable) material that erodes and absorbs. Alternatively, it can be constructed in such a way that it can be removed from the tube conduit or that it advances within the tube conduit for a period of time after implantation. For example, one or more filaments, such as sutures, can be placed in the tube conduit and removed or advanced by a doctor as desired on a later occasion or occasions.

An implant according to the invention has other applications apart from those in the field of intraocular implants. For example, the implant can be used for draining a hydrocele sac, regulating the flow between the hydrocele sac and the subcutaneous scrotum. People with ordinary experience in the art will appreciate that other applications of an implant according to the invention are possible, such as various modifications of the embodiments described herein, without departing from the scope of the invention as defined in the claims.

Brief description of the drawings

Figure 1A is a side view of a first embodiment of a drain implant;

Figure 1B is a front view of the drain implant shown in Figure 1A;

Figures 2A to 2C illustrate a discharge and insertion device of the drain implant of Figure 1A in the desired tissue, with Figure 2A showing the discharge and implant device before insertion, Figure 2B shows the discharge device e implant that are placed through the tissue, and Figure 2C shows the implant inserted after the discharge device has been removed;

Figure 3A is a side view of a second embodiment of a drain implant;

Figure 3B is a front view of the drain implant shown in Figure 3A;

Figure 3C is a cross-sectional view along the plane identified by line 3C-3C in Figure 3A;

Figure 4A is a side view of a third embodiment of a drain implant;

Figure 4B is a front view of the drain implant shown in Figure 4A;

Figure 5 illustrates a second embodiment of a discharge device with an implant inserted in the discharge device and with the procedure in a stage corresponding to that of Figure 2B;

Figure 6 illustrates an intraocular implant according to the invention with a cap that controls the flow of absorbable material manufactured in the tube conduit;

Figures 7A to 7D illustrate four variations of cross sections for a plug that controls flow;

Figure 8 illustrates an intraocular implant according to the invention with a plug that controls the flow made of absorbable material in the tube conduit and with lateral perforations partially obstructed by plugs made of absorbable material;

Figure 9 illustrates an intraocular implant according to the invention with filaments that control the flow in the tube conduit;

Figure 10 illustrates a front view of an intraocular implant with filaments that control the flow in the tube conduit;

Figure 11 illustrates an intraocular implant according to the invention with a filament that controls the knotted flow in the tube conduit; Y

Figure 12 illustrates an alternative structure of a filament that controls the flow.

Detailed description of the embodiments of the invention

Figures 1A and 1B show a side view and a front view, respectively, of a first embodiment of a drain implant 10 according to the invention. The implant 10 has a tube 12 having a conduit 14 to allow fluid flow between an inlet end of the implant and an outlet end of the implant. One or more lateral perforations 16 may be arranged around the circumference 12 near the inlet end, which allows access for fluid flow into the conduit 14.

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The implant 10 has an exit flange 18 at the exit end and a retention projection 20 near the entry end. The plane of the outer flange 18 can form an angle with the tube 12, with the angle selected to correspond to the angle between the surface of the tissue into which the implant 10 is to be inserted and the insertion axis 12 of the implant 10.

Figures 2A to 2C illustrate an introducer or discharge device 30 for implanting the implant 10 and the procedure for implanting the implant 10 with that discharge device 30. The discharge device 30 has a handle 32 and a tube 34 having a central perforation 36 to accommodate the implant 10 during the implantation procedure. The discharge device 30 has a beveled tip 38 to allow the penetration of the tissue 50 into which The implant is going to be inserted. In an alternative embodiment, the implant itself penetrates the tissue by its beveled tip at the inlet end.

An opening 40 is provided in the wall 34 of the discharge device 30. In this illustrated embodiment, the opening 40 allows the retention projection 20 and the outer flange 18 to protrude beyond the wall 34 when the implant 10 is loaded into the discharge device 30. Because it projects beyond the wall 34, the retaining projection 20 of the implant 10 can act as a hook during the implantation procedure.

As can be seen in Figure 1B, the flange 18 of the implant 10 has grooves 19 on each side. These grooves 19 correspond approximately to the width of the wall 34 of the discharge device 30 and house the wall 34 of the discharge device 30 when the implant 10 is loaded into the discharge device 30. Stretch marks 19 can have any suitable shape.

To use the implant 10 and the discharge device 30, the implant 10 is loaded into the discharge device 30 with the retention projection 20 protruding from the discharge device, as shown in Figure 2A. The discharge device 30, with the implant loaded inside, is then pressed through the tissue 50 through which drainage is desired, for example, the sclera of an eye. Figure 2B illustrates the discharge device 30 pressed through tissue 50.

To facilitate the introduction of the discharge device 30 and / or implant 10 into the tissue 50, the discharge device 30 can be oriented so that the beveled tip 38 forms a more acute angle with the fabric 50. Thus, for example, for example , the discharge device as shown in Figure 2A can rotate 180 degrees, that is, with the retention projection 20 facing up. In the case of an implant 10 that is placed within the sclera of the edge of an eye, this corresponds to the retention projection 20 that is on the opposite side 12 from the iris. When the discharge and implant device 30 adequately pass through the tissue 50, they can rotate to properly align the implant 10 in the tissue 50, with the flange 18 and the retention projection 20 oriented as desired with respect to the tissue 50.

Once the retention projection 20 has completely penetrated through the tissue 50, the discharge device 30 is removed. The retention projection 20 acts as a hook that engages the inner surface of the tissue 50, which causes the implant 10 to remain implanted in the tissue 50 when the discharge device 30 is removed. Figure 2C illustrates the implant 10 implanted in the tissue 50, with the discharge device 30 removed.

Since the tube 34 of the discharge device 30 is hollowed out, it can be used to inject fluid or viscous elastic material. In this way, the fluid can be injected into the anterior chamber of an eye in the implant to reduce the risk of hypotonia. Similarly, a viscous elastic material can be injected under the conjunctiva to help fill the flaccid vesicle that exists after implantation.

The implant 10 can be molded of a suitable material, for example silicone. To provide the conduit 14 of the implant 10, a thin wire can be used during the molding process. More than one cable can be used to have more than one tube conduit in the implant. The implant can alternatively be constructed of stainless steel or other suitable material. It must be coated with a suitable antifibrosis material, such as heparin.

The retention projection 20 can be formed of the same material as the rest of the implant 10. Alternatively, it can be made of a more flexible material to allow it to be flexed inwardly against the tube 12 of the implant 10 during penetration through the tissue 50 Alternatively, the retention projection 20 can be designed to initially rest relatively flat against the tube 12 for easier penetration and to prevent tearing of the tissue 50, which is to be extended outwardly by an expansion mechanism, for example a balloon, when the implant is implanted 10.

Figures 3A, 3B and 3C show a side view, front view, and cross section, respectively, of a drain implant 60 that is not part of the invention. Like the implant 10 shown in Figures 1A and 1B, the implant 60 in Figures 3A, 3B, and 3C has a tube 62 that has a conduit 64 and lateral perforations 66 that open within the conduit 64. The implant 60 has also an external flange 68 at the exit end and a retention projection 70 near the input end. In this case, the outer flange 68 projects beyond the outer surface 62 in all directions around the circumference 62.

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Figures 4A and 4B show a side view and a front view, respectively, which is also not part of the invention, of a drain implant 80, similar to implant 60 shown in Figures 3A, 3B, and 3C. The tip 82 of the implant 80 is conical, in contrast to the blunt tip 72 of the implant 60.

In an alternative structure, the implant can be manufactured with a closed end with a cut in it. The fluid can only pass through the device when the pressure increases sufficiently to open the cut. Alternatively, a different portion along the length of the tube conduit may be provided with such a structure.

Figure 5 illustrates an alternative embodiment of a discharge device 90 that is not part of the invention. In this embodiment, the opening 92 allows only the implant retention projection 84 to protrude beyond the wall 94 of the discharge device. The outer flange 86 is housed within the central perforation 96 of the discharge device 90. In this embodiment, the outer flange 86 must be folded or flexed to be housed within the central hole 96 of the discharge device 90. The outer flange 86 is elastic, so that when the implant is removed from the discharge device, the outer flange 86 extends to a relatively coplanar position with the outer surface of the tissue into which the implant is to be inserted.

Similarly, the retention projection 84 will also be constructed to be sufficiently elastic to allow it to be compressed and completely housed within the central perforation 96 of the discharge device 90. In addition, the discharge device 90 can be constructed by causing the tube 94 to have a continuous outer wall, without the opening 92. To facilitate removal of the implant from the discharge device, a pusher rod or cable can be located within the perforation of the unloading device By advancing the pushrod or push wire inside the discharge device against the implant, the doctor can force the implant out of the discharge device, thereby allowing the retention projection to expand outward to its relaxed initial position, allowing that way it fits inside the tissue surface.

Various mechanisms can be used, if desired, to offer different flow characteristics to the implant. It may be desirable to use implants with different flow characteristics for different patients and / or have an implant in which the flow characteristics can be changed after implantation in a particular patient.

U.S. patent application No. 08 / 975,386, filed on November 20, 1997, describes and illustrates different mechanisms to help control fluid flow, e.g. ex. aqueous humor, through an implant. Describes and illustrates the use of a cable or rod to control the flow in the tube conduit of an implant.

The effect of the flow control rod or cable is to reduce the cross-sectional area through which fluid flows for a particular length within the implant tube conduit. Because the flow is a function of the cross-section and length of the conduit through which it passes, the interposition of the rod or cable to control the flow serves to increase the flow resistance. In an intraocular implant, for example, this helps reduce the risk of hypotonia.

The configuration and dimensions of the flow control rod or cable can be selected according to the desired flow characteristics. It can have one or more internal perforations or external striations, any of which can be helically arranged to increase its length. It can be adjustable, moving it axially or rotatably, to modify the flow characteristics. Those skilled in the art will appreciate that numerous variations are possible for the configuration of the rod or cable to control the flow.

The rod or cable for controlling the flow may have its longitudinal axis aligned parallel with the axis of the tube conduit, although other orientations are possible. For example, a rod or cable for controlling the flow having a diameter slightly smaller than the tube conduit can be oriented transversely to the tube conduit. The rod or cable oriented transversely will have a short length, corresponding approximately to the diameter or conduit of the tube. It serves as an obstruction to the flow through the tube conduit, altering the flow characteristics. Another obstruction can be placed in the tube conduit to achieve similar results.

Another mechanism to help control fluid flow through an implant is the use of temporary obstruction. By obstructing the flow passage of the implant with an absorbable material or with a material that can be removed after implantation, for example by means of a laser tool or probe, resistance to flow can be reduced after implantation.

The use of temporary obstruction is advantageous in situations in which the flow through the implant is desired to be kept low at implantation, and also possibly for a period of time after implantation. For example, when an implant is implanted in the eye, the incision in the conjunctiva and / or possible tearing of the sclera around the implant provides potential flow ducts for aqueous humor. Thus, to reduce the risk of hypotonia, it is desirable to avoid or reduce the flow through the implant.

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in the implantation and during a later period. Once the conjunctiva and / or sclera have healed, the flow through the implant can be increased.

Temporary obstruction does not need to be limited to any specific part of the flow duct. For example, the lateral perforations and / or the implant tube conduit can be filled, partially or totally, with absorbable material. Thus, for example, as shown in Figure 6, a plug 106A of absorbable material can be place in the conduit 102 of the implant 100. With an absorbable material that is biodegradable by surface erosion, as the fluid is contacted and flows adjacent to the plug 106A, the material of the plug 106A is absorbed into the fluid, thereby reducing the dimensions of the plug 106A. As the dimensions of the plug 106A are reduced. resistance to flow through the implant is similarly reduced. Alternatively, an absorbable material that biodegrades by volume erosion can be used. Absorbable (biodegradable) materials are known and used, and such materials are described, for example, in Middleton & Tipton, "Synthetic Biodegradable Polymers as Medical Devices", Medical Products and Biomaterials. March 1998

Figure 6 shows the plug 106A that only partially fills the conduit 102, although it will be appreciated that the plug 106A can completely fill the conduit 106A. In that case, the fluid flow would be completely blocked initially. The fluid flow begins only after the plug 106A has been sufficiently absorbed to provide a path for fluid flowing out of the implant.

An absorbable cap may be used for any suitable implant configuration, which includes implants with rods to control the flow or other obstructions that control the flow. Similarly, an absorbable cap can have any suitable configuration and dimensions, selected according to the desired flow characteristics. If desired, more than one absorbable cap may be used.

Some possible cross-sectional shapes for alternative absorbable caps are shown in Figures 7A to 7D. The absorbable plug 106A has a circular cross section. The absorbable plug 106B is similar to the absorbable plug 106A with the addition of external streaks 108B. The absorbable plug 106C has a flat surface 110C. The absorbable plug 106D has a longitudinal bore 112D. Alternative constructions include external streaks that combine and internal perforations, which change the number of them, and / or arrange them helically or in any other suitable configuration. The absorbable cap may be conical or in any other suitable way. It will be appreciated that the configuration of the absorbable cap will affect the absorption of the absorbable cap, with the areas in contact with the fluid to be absorbed first.

Figure 8 shows the use of an absorbable plug 106A in conjunction with the clogged side perforations 104. Each of the lateral perforations 104 is partially clogged by the absorbable plugs 114, each of which has a central perforation 116. As with absorbable plug 106A in conduit 102, absorbable plugs 114 in lateral perforations 104 may have any suitable configuration, and may be used in conjunction with any absorbable plug configuration in the conduit of the tube or without any absorbable plug in the tube duct.

Figures 9 to 11 show alternative mechanisms for temporary and / or partial obstruction of the flow duct. In Fig. 9, the intraocular implant 120 has a number of filaments 126 that control the flow in the conduit 122. The filaments 126 that control the flow serve to alter the flow characteristics through the implant, either partially or totally obstructing the flow through the implant. The number and / or size of the filaments may vary as desired, and the filaments may be of any suitable material. For example, ordinary sutures, such as polypropylene sutures, can be used.

In a period of time after implantation, one or more filaments 126 that control the flow can be removed from the implant (or advanced within the implant). Additional filaments can be removed (or advanced) later. In this way, the obstruction to the flow through the implant can be altered, immediately or for a period of time, after the implantation procedure has taken place.

It will be appreciated that the ability to remove or advance one or more filaments for a while allows the physician to alter the characteristics of the implant flow according to the needs of the patient. For example, in a certain period of time after the implant has been implanted in a patient's eye, the doctor can check the intraocular pressure of the eye and determine if one or more filaments should be removed or advanced to increase or reduce the flow to through the implant The patient can be monitored periodically, and the filaments can be left in place, removed or advanced as appropriate over a period of time.

The ability to remove the filaments is useful in the event that the implant has to be clogged. In such a case, the doctor can remove one or more filaments to restore the proper flow through the implant.

Figure 10 shows a front view of an implant with a plurality of filaments 126 that control the flow in the conduit 122. It will be appreciated that the filaments 126 can be disposed within the conduit 122 in any suitable manner, and the shape and configuration of filaments 126 are not limited to those shown. For example, the filaments can have different cross sections (for example, oval, semicircular, irregular, hollowed out,

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etc.) and different sizes. The cross-sectional shapes and dimensions may vary along the length of a single filament. Each of the filaments in a single implant can have different configurations, for example, different cross-sectional shapes and / or dimensions. With different filaments in the implant, the doctor can selectively remove (or advance) the appropriate filament or filaments according to the desired flow characteristics. For example, if a small increase in flow is desired, a filament with a small cross-section can be removed, and if a large increase in flow is desired, a filament with a larger cross-section can be removed.

Figure 11 shows an implant in which a single filament 128 for controlling the flow having a node 130 is placed inside the duct 122. The node 130 serves to increase the flow obstruction. Alternatively, a plug or other obstruction may be attached to filament 128, and more than one filament 128 may be used with a knot, plug or other obstruction attached. Similar to the use of filaments of different shapes and / or sizes, filaments having knots or plugs of different shapes and / or sizes can be used, which allow selectively withdrawing or advancing according to the desired flow characteristics.

Figure 12 shows an alternative structure of a filament 132 for controlling the flow in which the size of the cross-section of the filament varies along its length. The illustrated filament 132 has three different sections. Section 138 on the end of the filament has the smallest diameter, the contiguous section 136 has a slightly larger diameter, and the remainder 134 of the filament has an even larger diameter. The remainder 134 of the filament can be sized to correspond to the diameter of the tube conduit, the sections 136 and 138 being progressively smaller. Thus, with a tube conduit having a diameter, for example, of 100 microns, the filament can also have a diameter of 100 microns, with progressive steps down, for example, 20 microns. Of course, other dimensions can be used, and the rest 134 of the filament does not need to be the same size as the tube conduit. In the initial positioning, the filament 132 is located within the conduit of the implant tube with section 138 near the inlet end and with part of section 134 located within the tube conduit near the outlet end. When it is desired to increase the flow in the implant, the filament 132 can be partially removed so that only section 134 leaves the tube conduit. Thus, the obstruction inside the tube conduit decreases, thereby increasing the flow. Later, if desired, the other sections can be removed successively. Alternatively, the filament can also advance within the tube conduit to further limit flow.

The variations of the filament shown in Figure 12 are possible, with the sections that are aligned along the filament in a desired pattern. The concept of a single filament which can be partially removed or advanced in successive increments to vary the flow in stages can be achieved additionally or alternatively using knots or plugs of different shapes and / or sizes along the length of a filament.

A filament that controls the flow according to the invention can be completely separated from the implant and inserted into the implant some time after implantation, or the filament can be partially implanted at the time of implantation, with the option of its further advance into the implant later.

An implant that has filaments to control the flow that can be removed (and / or that can be advanced) can be implanted using a discharge device 30 as shown in Figure 2A. In such a case, the filaments that extend outside the outlet end of the implant can be housed in the central bore 36 of the discharge device 30. Alternatively, with an opening 40 of suitable size in the wall 34 of the discharge device 30, the filaments can pass outside the discharge device 30.

When the implant is implanted in one eye, the filaments to control the flow can be oriented for extension under the conjunctiva away from the implant. The filaments used can be long enough to extend outside the implant beyond the cut made in the conjunctiva to insert the implant. In this case, after implanting the implant, the doctor can pass the loose ends of the filaments under the conjunctiva to remove them from the cut. When it is desired to remove one or more of the filaments, a small cut can be made in the conjunctiva near the ends of the filaments, and the filaments can be pulled through that cut. Because these ends are far from the implant and the anterior cut made in the conjunctiva, the potential trauma of the eye is reduced.

To fix the filaments in place and facilitate access to them later, the loose ends can be sutured to the adjacent tissue, for example, the sclera. This can be done either with additional sutures or with the filaments themselves. In the latter case, the suture needles can be attached to the loose ends of the filaments to facilitate suture of the filaments after implant implantation.

It will be appreciated that various features of the embodiments described above can be combined as desired. For example, the filaments to control the flow can be made of absorbable material, leaving the option for the doctor to physically remove the filaments or allow them to be absorbed. Additionally or alternatively, the plugs or other obstructions subject to the filaments can be made of material

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absorbable Different filaments, plugs or obstructions can be made of materials with different absorption rates, and / or they can be made of a combination of materials with different degrees of absorption.

As those skilled in the art will also appreciate, the various embodiments of the implants, manufacturing procedures, discharge devices, and implantation procedures described hereinbefore are offered by way of example only. Various changes, modifications and variations can be applied to the described embodiments without departing from the scope of the invention, defined by the appended claims.

Claims (15)

1. An implant (10, 100, 120) to regulate the flow of fluid comprising: a tube (12) comprising an inlet end, an outlet end and a conduit (14, 102, 122) of the tube extending between the inlet end and the outlet end to allow fluid to flow through of the conduit (14, 102, 122) of the tube; a flange (18) located at the outlet end of the tube (12) and a retaining projection (20) near the inlet end, the flange (18) having grooves (19) on each side of the flange (18); Y a means to temporarily block, totally or partially, the flow of fluid through the tube conduit. 2. An implant according to claim 1, wherein the means for temporarily blocking the flow of fluid, 10 comprises absorbable material located within the conduit (14, 102, 122) of the tube, in which initially the absorbable material serves to partially or totally obstruct the flow through the conduit (14, 102, 122) of the tube and in which The absorbable material erodes as it comes into contact with the fluid so that the obstruction of the flow through the conduit (14, 102, 122) of the tube is reduced over time. An implant according to claim 2, wherein initially the absorbable material substantially fills the conduit (14, 102, 122) of the tube in order to prevent the flow from passing through the conduit of the tube.

Four.

An implant according to claim 2, wherein initially the absorbable material partially fills the conduit (14, 102, 122) of the tube in order to allow partial flow through the tube conduit.

5.

An implant according to claim 1, wherein the means for temporarily blocking the flow of fluid comprises

20 one or more filaments to control the flow located within the conduit (14, 102, 122) of the tube, in which initially the one or more filaments to control the flow serve to partially or totally obstruct the flow through the tube conduit and wherein at least one filament (126) to control the flow can be displaced with respect to the conduit (14, 102, 122) of the tube to change the obstruction of the flow through the conduit of the tube. An implant according to claim 5, wherein initially the one or more filaments (126) to control the flow substantially fill the tube conduit in order to prevent flow through the conduit (14, 102, 122) of the tube. An implant according to claim 5, wherein initially the one or more filaments (126) to control the flow partially fill the tube conduit in order to allow partial flow through the tube conduit. An implant according to claim 5, further comprising a plug attached to one or more of said filaments 30 to control the flow.

9.

An implant according to claim 5, wherein one or more of said filaments for controlling flow have a knot (130) therein.

10.

An implant according to claim 5, wherein at least one filament (126) to control the flow can be removed from the conduit (14, 102, 122) of the tube to reduce the obstruction of the flow through the conduit of the tube.

An implant according to claim 10, wherein at least one filament (126) to control the flow can be completely removed from the conduit (14, 102, 122) of the tube to reduce the obstruction of the flow through the conduit of the tube. An implant according to claim 10, wherein at least one filament (126) to control the flow can be partially removed from the tube conduit to reduce the obstruction of the flow through the tube conduit. An implant according to claim 5, wherein at least one filament (126) to control the flow can be advanced within the tube conduit to increase the obstruction of the flow through the tube conduit.

14.

An implant according to claim 5, comprising at least two filaments (126).

fifteen.

An implant according to claim 14, wherein two of the filaments (126) have different dimensions in cross section.

16. An implant according to claim 14, wherein each of at least two filaments has a cap attached thereto, the caps having at least two different filaments in cross-sectional dimensions. 9 17. An implant according to claim 14, wherein each of at least two of the filaments has a knot (130) in it, having the knots in at least two different filaments dimensions.

18.

An implant according to claim 5, wherein at least one filament (126) for controlling the flow has different areas along its length with different dimensions in cross section.

19.

An implant according to claim 5, wherein at least one filament (126) for controlling the flow is made of absorbable material.

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